Daikenchuto for Intestinal Dysmotility and Prevention of Postoperative Paralytic Ielus After Pancreaticoduodenectomy

NCT01607307 | Unknown Phase 2 DMC

• 2 other identifiers: JAPAN-PDUMIN000007975
• Study Type: interventional
• Target: 220
• Locations: 1 country
• Sites: 5

Brief Summary

A multicenter randomized-controlled trial of daikenchuto (TJ-100), a traditional Japanese herbal medicine (Kampo), to investigate its effect on intestinal dysmotility and for the prevention of postoperative paralytic ileus.

Conditions

Paralytic Ileus

Keywords

daikenchuto; postoperative ileus; pancreaticoduodenectomy

Outcome Measures

Primary Outcomes (2)

• Incidence of postoperative paralytic ileus (including the duration of paralysis)

  Delayed passage of first flatus for 72 hours (3.0 days) after surgery, or a postoperative condition that requires an intervention for the ileus. Every 12 hours is counted as 0.5 postoperative day and every 24 hours as 1.0 postoperative day.

  72 hours

• The duration until the first flatus after surgery.

  The first passages of flatus will be confirmed by patients themselves and they will inform it to the medical staffs.

  14 days

Secondary Outcomes (7)

• QOL assessment by the Gastrointestinal Symptom Rating Scale (GSRS) Score (Japanese Version)

  7 days

• Abdominal pain and abdominal distention scores on the Visual Analogue Scale.

  3 days

• The change ratio of abdominal circumference.

  3 days

• The incidence of postoperative complication.

  14 days

• The length of postoperative hospital day.

  30 days

Study Arms (2)

Oral/enteral TJ-100 solution

ACTIVE COMPARATOR

Oral/enteral TJ-100 solution

Drug: Oral/enteral TJ-100 solution

Oral/enteral placebo solution

PLACEBO COMPARATOR

Oral/enteral placebo solution

Drug: Oral/enteral placebo solution

Interventions

Oral/enteral TJ-100 solution DRUG

Oral TJ-100 solution (5 g tid, 15 g/day) given immediately before meals or every 8 h from preoperative day 3 to postoperative day 7 for 10 consecutive days. A diluent TJ-100 solution given immediately after surgery and on postoperative day 1 via Argyle enteral feeding tube (10 Fr), which terminates in the jejunum to prevent aspiration pneumonia.

Also known as: A

Oral/enteral TJ-100 solution

Oral/enteral placebo solution DRUG

Oral placebo solution (5 g tid, 15 g/day) given immediately before meals or every 8 h from preoperative day 3 to postoperative day 7 for 10 consecutive days. A diluent placebo solution given immediately after surgery and on postoperative day 1 via Argyle enteral feeding tube (10 Fr), which terminates in the jejunum to prevent aspiration pneumonia.

Also known as: B

Oral/enteral placebo solution

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with periampullary tumors (extrahepatic bile duct tumor, tumors of ampulla of Vater and duodenal tumor) and pancreatic tumors (pancreatic cancer, intraductal papillary mucinous neoplasm of the pancreas, pancreatic endocrine tumor and pancreatic neuroendocrine tumor) of the head of the pancreas who are scheduled to undergo PD.
• Age of at least 20 years old at the time of registration.
• All patients provided written informed consent before initiation of study-related procedures.

You may not qualify if:

• Clinically problematic cardiac disease.
• Liver cirrhosis or active hepatitis.
• Severe pulmonary disease (interstitial pneumonia, pulmonary fibrosis, pulmonary emphysema etc.).
• Chronic renal failure requiring hemodialysis.
• Other malignant disease that can influence the adverse effect.
• Patients with tumors requiring resection of colon.
• Patients who are expected to have severe intra-abdominal adhesion due to past surgical history or past peritonitis history.
• Patients who had used gastrointestinal prokinetic medication, antipsychotic medication or antidepressants.
• Patients who had used Japanese herbal (Kampo) medicines within 4 weeks before registration.
• Pregnant or lactating women.

Sponsors & Collaborators

• Wakayama Medical University: lead
• Epidemiological and Clinical Research Information Network: collaborator

Study Sites (5)

Nagoya University

Nagoya, Aichi-ken, Japan

Location

Hiroshima University

Hiroshima, Hiroshima, Japan

Location

Osaka University

Suita, Osaka, Japan

Location

Shizuoka Cancer Center Hospital

Shizuoka, Shizuoka, Japan

Location

Wakayama Medical University

Wakayama, Wakayama, 641-8510, Japan

Location

Related Publications (2)

• Maeda H, Okada KI, Fujii T, Oba MS, Kawai M, Hirono S, Kodera Y, Sho M, Akahori T, Shimizu Y, Ambo Y, Kondo N, Murakami Y, Ohuchida J, Eguchi H, Nagano H, Sakamoto J, Yamaue H. Transition of serum cytokines following pancreaticoduodenectomy: A subsidiary study of JAPAN-PD. Oncol Lett. 2018 Nov;16(5):6847-6853. doi: 10.3892/ol.2018.9422. Epub 2018 Sep 7.

  PMID: 30333892 DERIVED

• Okada K, Kawai M, Hirono S, Fujii T, Kodera Y, Sho M, Nakajima Y, Satoi S, Kwon AH, Shimizu Y, Ambo Y, Kondo N, Murakami Y, Ohuchida J, Eguchi H, Nagano H, Oba MS, Morita S, Sakamoto J, Yamaue H; JAPAN-PD Investigators. Evaluation of the efficacy of daikenchuto (TJ -100) for the prevention of paralytic ileus after pancreaticoduodenectomy: A multicenter, double-blind, randomized, placebo-controlled trial. Surgery. 2016 May;159(5):1333-41. doi: 10.1016/j.surg.2015.11.019. Epub 2015 Dec 31.

  PMID: 26747224 DERIVED

MeSH Terms

Conditions

Intestinal Pseudo-Obstruction

Condition Hierarchy (Ancestors)

Ileus; Intestinal Obstruction; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Hiroki Yamaue, M.D., Ph.D.

  Second Department of Surgery, Wakayama Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 16, 2012
• First Posted: May 30, 2012
• Study Start: August 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: August 1, 2016
• Last Updated: December 18, 2013

Record last verified: 2012-08

Locations

JP (5)